Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes
| Autor: | Shamir R, Mehta, Jean-Pierre, Bassand, Susan, Chrolavicius, Rafael, Diaz, John W, Eikelboom, Keith A A, Fox, Christopher B, Granger, Sanjit, Jolly, Campbell D, Joyner, Hans-Jurgen, Rupprecht, Petr, Widimsky, Rizwan, Afzal, Janice, Pogue, W C L, Wu |
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| Rok vydání: | 2010 |
| Předmět: |
Male
medicine.medical_specialty Acute coronary syndrome Ticlopidine medicine.medical_treatment Myocardial Infarction Hemorrhage Kaplan-Meier Estimate Coronary Angiography Clopidogrel aspirin acute coronary syndromes Double-Blind Method Internal medicine medicine Humans cardiovascular diseases Myocardial infarction Acute Coronary Syndrome Angioplasty Balloon Coronary Coronary Artery Bypass Aged Aspirin Unstable angina business.industry Hazard ratio Percutaneous coronary intervention General Medicine Middle Aged medicine.disease Combined Modality Therapy Stroke Cardiovascular Diseases Research Design Cardiology Female business Elinogrel Platelet Aggregation Inhibitors medicine.drug |
| Zdroj: | New England Journal of Medicine. 363:930-942 |
| ISSN: | 1533-4406 0028-4793 0033-5452 |
| Popis: | A b s t r ac t Background Clopidogrel and aspirin are widely used for patients with acute coronary syndromes and those undergoing percutaneous coronary intervention (PCI). However, evidencebased guidelines for dosing have not been established for either agent. Methods We randomly assigned, in a 2-by-2 factorial design, 25,086 patients with an acute coronary syndrome who were referred for an invasive strategy to either double-dose clopidogrel (a 600-mg loading dose on day 1, followed by 150 mg daily for 6 days and 75 mg daily thereafter) or standard-dose clopidogrel (a 300-mg loading dose and 75 mg daily thereafter) and either higher-dose aspirin (300 to 325 mg daily) or lower-dose aspirin (75 to 100 mg daily). The primary outcome was cardiovascular death, myocardial infarction, or stroke at 30 days. Results The primary outcome occurred in 4.2% of patients assigned to double-dose clopidogrel as compared with 4.4% assigned to standard-dose clopidogrel (hazard ratio, 0.94; 95% confidence interval [CI], 0.83 to 1.06; P = 0.30). Major bleeding occurred in 2.5% of patients in the double-dose group and in 2.0% in the standard-dose group (hazard ratio, 1.24; 95% CI, 1.05 to 1.46; P = 0.01). Double-dose clopidogrel was associated with a significant reduction in the secondary outcome of stent thrombosis among the 17,263 patients who underwent PCI (1.6% vs. 2.3%; hazard ratio, 0.68; 95% CI, 0.55 to 0.85; P = 0.001). There was no significant difference between higher-dose and lower-dose aspirin with respect to the primary outcome (4.2% vs. 4.4%; hazard ratio, 0.97; 95% CI, 0.86 to 1.09; P = 0.61) or major bleeding (2.3% vs. 2.3%; hazard ratio, 0.99; 95% CI, 0.84 to 1.17; P = 0.90). Conclusions In patients with an acute coronary syndrome who were referred for an invasive strategy, there was no significant difference between a 7-day, double-dose clopidogrel regimen and the standard-dose regimen, or between higher-dose aspirin and lower-dose aspirin, with respect to the primary outcome of cardiovascular death, myocardial infarction, or stroke. (Funded by Sanofi-Aventis and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00335452.) |
| Databáze: | OpenAIRE |
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